Post-Market Prospective Clinical Follow Up Study on the Symptomatic Treatment of Musculoskeletal Pain Through Sensory Nerve Stimulation Using the Compex SP8.0 Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Change in pain level
研究概览
简要总结
This post-market clinical study of the SP8.0 Compex device aims to comprehensively assess the safety and performance of the device when used in accordance with the approved Instructions for Use. The results of this study will also support the clinical evaluation of the next-generation wireless product currently under development.
The Compex Consumer devices contain different programs, such as conditioning, fitness, recovery, massage, rehabilitation, and pain management.
This study will utilize the Compex SP 8.0 pain management programs, with the aim of assessing the effectiveness of the treatment provided by the device in managing pain through different physiological mechanisms.
详细描述
Subjects will be treated with the Compex device according to the intended use of the device and as per routine clinical practice. Clinical data will be collected in healthcare settings as part of the routine clinical practice and according to the study protocol. Additional data points will be recorded pre and post use of the advised treatment with the compex device using an electronic patient diary.
Adult subjects who require symptomatic treatment of musculoskeletal pain (nociceptive pain or neuropathic/nociplastic pain), with a Numeric Pain Rating Scale (NPRS) score of 4 or more at baseline will undergo Electrical Nerve Stimulation with the Compex SP8.0 device at home for up to 4 weeks.
The investigator will train subjects on how to use the device at home and a guide will be provided to each subject to help them when using the device at home.
For all subjects the first treatment session will be performed by the investigator at the clinic.
The assessment of pain level will be completed by the investigator during onsite visits: before treatment (Baseline Visit), after 2 weeks of treatment and at the 4 weeks/End of study visit. Additionally, subjects will be asked to record their level of pain before and immediately after each treatment session on an electronic diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects currently experiencing musculoskeletal pain with a Numeric Pain Rating Scale (NPRS) score of 4 or more at baseline.
- •Subjects are considered suitable to self-administer stimulation of motor nerves or stimulation of sensory nerves at home, based on the Investigator's judgement.
- •Subjects are suitable to receive treatment using the Compex SP8.0 device Pain management programs (pre-set parameters) for up to 4 weeks, based on the Investigator's judgement.
- •Subject, both male and female, ≥ 18 years of age at the time of consent
- •Subject has reviewed the IEC-approved consent form, has properly consented per the protocol and has documented their consent to participate in the study by signing the Ethics-approved consent form.
- •Subject does not meet any of the
排除标准
- •Exclusion Criteria:
- •Presence of Implanted electronic devices (e.g., pacemakers, defibrillators)
- •Skin conditions that contraindicate TENS use (e.g., rashes, wounds in electrode placement areas).
- •Known allergy to electrode materials.
- •Current participation in another clinical study that could interfere with this study's outcomes.
- •Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers
- •Subjects who are not able to read and understand indications and contraindications of the device
- •Subjects who are not able to sense auditory and visual signals
- •Subjects who are being treated with any other electrotherapy device for pain relief.
- •Subjects who are being treated with acupuncture
- •Participation in another clinical study within 30 days prior to screening
研究组 & 干预措施
High Frequency TENS
Based on the diagnosis and the type of pain , subjects will be assigned to the High Frequency TENS (gate control principle at 50-150 Hz) treatmet group, which includes the following preset programs:
- Pain management TENS
- Epicondylitis
- Tendinitis.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device (Device)
Low frequency TENS
Based on the diagnosis and the type of pain , subjects will be assigned to the Low Frequency TENS (endorphinic TENS at 5 Hz) treatmet group, which includes the following preset programs:
- Muscle pain
- Neck pain
- Back pain
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) with the Compex SP8.0 device (Device)
结局指标
主要结局
Change in pain level
时间窗: From enrollment to full recovery or end of treatment at week 4
Improvement in pain demonstrated by the score on the Numerical Pain Rating Scale (NPRS) at the beginning and the end of the treatment period when using the pain management treatment programs of the device. The Numerical Pain Rating scale (NRS)is a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". The overall success of the study as well as the evaluation of the primary endpoint will be based on the proportion of subjects who experience a ≥ 2-point decrease in pain scores at the end of the treatment period as compared to baseline.
次要结局
- Incidence of Treatment-Emergent Adverse Events(From enrollment to full recovery or end of treatment at week 4)